COAGULATION CONTROL, LEVEL III

System, Multipurpose For In Vitro Coagulation Studies

U. S. DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Coagulation Control, Level Iii.

Pre-market Notification Details

Device IDK870687
510k NumberK870687
Device Name:COAGULATION CONTROL, LEVEL III
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-19
Decision Date1987-04-20

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